1. Statement of the Invention
The present invention is directed to the treatment of performance anxiety. More specifically the invention provides a composition and method for treating performance anxiety.
2. Background Art
Many people experience a "normal" fear of public speaking. However, for some people that fear that he or she may do something or act in a way that will be humiliating or embarrassing is sufficient to cause avoidance behavior to the point of interfering with occupational or social functioning. In this situation, a diagnosis of performance anxiety may be appropriate. Public speaking is the most common fear in social phobia (Uhde et al., 1991), followed by eating in public, writing in public, and using public lavatories.
Social phobia is one of several major anxiety disorders and can constitute a chronic and disabling illness. There is currently no FDA approved treatment for social phobia although case reports suggest efficacy for several drug classes (the beta adrenergic receptor blockers, including propranolol hydrochloride (10-120 mg) (The Handbook of Psychiatric Drug Therapy, (Little, Brown and Co., Boston/Toronto, Pub., Ch. 7, p. 142) and The Psychiatric Drug Handbook, (Mosby Year Book, Pub., Ch. 7, pp. 247-248) benzodiazepines; and monoamine oxidase inhibitors).
Social phobia is one of seven major anxiety disorders. It is felt to be a discrete and separate illness from panic disorder or generalized anxiety disorder (Liebowitz et al., 1985). Its essential feature is a persistent fear of one or more situations (the social phobic situations) in which the person is exposed to possible scrutiny by others and fears that he or she may do something or act in a way that will be humiliating or embarrassing. Social phobia results in marked anticipatory anxiety when an affected person is confronted with the need to enter into a phobic situation.
The magnitude of this problem is unknown, but estimates of prevalence range from 0.9% to 2.6% of urban populations (Liebowitz et al., 1985). Social phobia may often co-exist with panic disorder (Stein et al., 1989). In one report, nearly one-half (46%) of a group of patients with panic disorder had concomitant diagnoses of social phobia. The importance of social phobia is emphasized by limited data which suggest a high morbid risk for major depression and alcoholism in this population. The disorder is chronic and can be disabling.
Social phobia in general, and performance anxiety in particular, are among the most neglected major anxiety disorders in terms of treatment. Pharmacotherapy has focused on trials of monoamine oxidase inhibitors (MAOIs) (Liebowitz et al., 1985). Few reports have resulted from controlled clinical trials. The .beta.-blockers have shown some efficacy, generally on performance anxiety when a peripheral component was central to the phobic situation (e.g. musical performance)(Brewer C, Lancet ii:435, 1972; Hartley et al., Brit. J. Psychiatry 142:512-517, 1983; James et al., Lancet ii:952-954, 1977). The MAOIs have well recognized drawbacks to their use (side effects, dietary restrictions) and the benzodiazepines have the disadvantage of dependence liability, further complicating use in patients with alcohol abuse. No reports have been published where the symptom of sweating as an anxiety symptom associated with public speaking was specifically targeted for treatment. Thus, there exists a need for a safe, effective medication for the treatment of both the anxiety and sweating associated with performance anxiety.
The present invention meets this need by providing a fixed-dose combination of a .beta.-blocker and an anti-diaphoretic in a single dosage form effective to treat specific anxiety symptoms associated with the performance anxiety of public speaking. It is anticipated that selected patients with social phobia related to other performance tasks would also benefit. Propranolol hydrochloride controls palpitations, tachycardia, tremor and voice quavering while glycopyrrolate controls diaphoresis (sweating). These two medications have never previously been combined in a single pill. This medication provides, in a convenient form, a type of comprehensive medical treatment for anxiety symptoms that has not been previously available.